August 31, 2010 Linda Bruemmer Director, Environmental Health Division Minnesota Department of Health P.O. Box 64975 St Paul, MN 55164‐0975 Re: Minnesota Chemicals of High Concern List RE: Concerns & Recommendations Regarding Minnesota Chemicals of High Concern List Dear Ms. Bruemmer, On behalf of a Coalition of the trade associations listed below (the Coalition), we appreciate the continued opportunity to participate in Minnesota’s efforts to comply with the mandates set forth in 2009 Session Law Chapter 37 (HF 2123)1. We respectfully submit this letter expressing some concerns with some of the sources2 and methodology that were used in populating Minnesota’s Chemical of High Concern (CHC) list, released July 1, 2010. Per the discussion during the workshop on July 15, this letter provides some recommendations on how to revise the current (CHC) list. We urge the Department to consider these recommendations, as this list will be crucial in identifying meaningful priority chemicals and defining chemicals policy in Minnesota. Specifically, we have concerns about the wholesale adoption of the Maine Chemicals of High Concern list without any additional analysis by DPH. Similar to the CHAMP criteria screening that the Department used for HPV chemicals the Maine CHC should go through the same thoughtful analysis by the Department. We fully understand that resources have constrained the level of analysis and review that could take place by the Department on the extensive Maine CHC list. However, below we provide recognition of limitations of the Maine CHC list that need to be considered. Additional review and scrutiny of the Maine CHC List are essential to ensuring that the priority chemicals selection process for the Minnesota CHC list has a sound foundation of authoritative conclusions. 1
Omnibus Bill HF 2123 ‐ https://www.revisor.mn.gov/laws/?id=37&year=2009&type=0 (Article 1, Sections 47‐52, 63) Minnesota’s Chemical of High Concern List Methodology report (http://www.health.state.mn.us/divs/eh/hazardous/topics/toxfreekids/chclist/methodology.pdf ) 2
As you know, the Coalition supports policies that stimulate Green Chemistry innovation and the development of sustainable technologies. A prioritization of chemicals must be done in a way that is informative and focuses on those substances that are of greatest, known concern to human health and the environment. As such, generally we support:  Safety‐based prioritization to identify chemicals of highest concern through consideration of exposure, use, and hazard data,  A “weight‐of‐evidence” approach to chemicals prioritization that evaluates all authoritative information on hazard traits, and considers the most severe hazards first, and  A process of informed substitution that considers the functional impacts of alternative technologies for each product category, as well as the technological and commercial feasibility of “safer” chemicals. It is our belief that by using these key elements to identify, prioritize, assess, and manage high priority chemicals, the Department will be able to focus its limited resources on the chemicals and exposures of greatest impact to human health. Our comments below discuss specific recommendations and revisions for the Minnesota CHC list published on July 1st. Comments on the Chemicals of High Concern List As discussed in our earlier comments, the Maine Chemicals of High Concern list contains several flaws with regard to prioritizing chemicals through an authoritative sources approach. Section 48 (c) of the Statute provides useful guidance in directing the Department to authoritative entities for chemicals known to present the hazards of concern. Most of the statutory sources are highly regarded; specifically, The U.S. Environmental Protection Agency (EPA), California Prop 65 chemicals identified under section 25249.8(b) and chemicals that will be identified within European Union’s Registration, Evaluation, Authorization and restriction of Chemicals (REACH) Annex XIV are all credible. However, as discussed earlier, the Maine CHC list as published and contained in the Department’s CHC list, contains flaws that do not meet the comparative authoritative bodies listed in the statute. While we understand resources are constrained, we recommend review and revision of Minnesota’s CHC list instead of a wholesale adoption of the Maine CHC. This review will provide a more prioritized consideration of authoritative data sources for the CHC list and will lead to more informed decisions on the priority chemicals selection process. Specifically, the following data sources for the Maine and Minnesota CHC lists should be reviewed and revised to focus on more authoritative and final listings or excluded from inclusion in the Minnesota CHC list due to a lack of an authoritative conclusion. i. CANADA The "PBiT" interim categorization list from Canada, a total of 393 chemicals, was inappropriately selected. This includes all chemicals modeled as PBT, including those that even Canada indicates are Low and Medium Confidence outcomes. After Canada completed categorization, the list of likely PBTs numbered 77. Since that time, Canada’s detailed assessments are further narrowing the scope, with action being taken on some chemicals of known concerns while others have been set aside. MDH should use Canada’s final list, focusing on those chemicals and uses where risk management action has been taken. Most of the chemicals on the interim list were not included in Canada's final "Top Priority Challenge" 200 chemicals for further data collection and regulatory action. 2
Recommendation: Chemicals included in Minnesota’s CHC list should only be the chemicals Categorized as Environmental PBT appearing in the "Top 200" high priority DSL categorized chemicals. http://www.chemicalsubstanceschimiques.gc.ca/challenge‐defi/list‐eng.php ii. OSLO‐PARIS CONVENTION (OSPAR) MDH selected two lists from OSPAR, the Convention that seeks to protect the North Sea from pollution. The first is OSPAR's full list of 310 substances of possible concern; the second is OSPAR's list for "Priority Action" of 50 chemicals. Since OSPAR criteria for Bioaccumulation and Persistence are lower and not aligned with the criteria of any other regional or national jurisdiction (i.e., the lowest threshold for the bioaccumulation concentration factor (BCF); see Cut‐Off Values for the Selection Criteria of the OSPAR Dynamic Selection and Prioritization Mechanism for Hazardous Substances3) neither list should be a source for Minnesota’s published list of chemicals of high concern. Since this source is old, it doesn’t take into account findings through the European Union’s PBT process where a detailed review was conducted it should be excluded from the CHC list. That EU process resulted in 23 chemicals that fulfilled PBT criteria, not 310. Recommendation: MDH should use the updated EU PBT list and not the OSPAR list. Chemicals included should be those PBT's "fulfilling criteria" from the EU review process at: http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=pbt i. EU ENDOCRINE DISRUPTION PROGRAM The EU Endocrine Disruption list was published in 1999. Starting from a nominated group of over 500 chemicals, a set of 194 was identified by a consultant as having "evidence of endocrine disruption activity". Little has been done since then to narrow this list to those of possible concern, including the absence of a deliberative regulatory technical process to have an in‐depth review of the data from all interested stakeholders and to take a more rigorous decision. It does not represent any level of scientific consensus. In fact, the EU's Science Advisors on the EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) did “not find the source material, methodology and selection criteria used to be scientifically adequate” and concluded “that there are important shortcomings in the present approach” (EU CSTEE, Opinion on BKH Consulting Engineers Report, http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out73_en.print.htm). Recommendation: Absent the in‐depth review and lack of any other significant improvements since 1999, this is a weak source and should be removed. ii. ENDOCRINE DISRUPTION (ED) ENDPOINT There is a strong point of view from many scientists that ED is a mode of action, not a toxicological endpoint. The potential to interact with the endocrine system does not necessarily constitute a risk and does not necessarily translate to an adverse physiological effect. The EU CSTEE states that: “It is important to realize that endocrine disruption is not a toxicological endpoint per se as is cancer or allergy, but that it is a descriptor for a functional change that may lead to adverse health effects. Rather, endocrine disruption should be seen in the context of well‐established endpoints, primarily reproductive toxicity and impaired development” (EU CSTEE, Opinion on BKH Consulting Engineers Report http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out73_en.print.htm). MDH’s published list already captures reproductive/developmental endpoints. The selected sources of 3
See: http://www.ospar.org/documents/DBASE/DECRECS/Agreements/05‐09e_Cut‐off‐value%20agreement.doc 3
endocrine disrupting chemicals that MDH used to populate the published list of chemicals of high concern should be removed. Nevertheless, MDH refers to its characterization of a “toxic endpoint” for the endocrine system in its July 2008 Statement of Need and Reasonableness relating to health risk limits for groundwater (www.health.state.mn.us/divs/eh/risk/rules/water/hrlsonar08.pdf). What is actually described is an Nevertheless, MDH refers to its characterization of a “toxic endpoint” for the endocrine system in its July 2008 Statement of Need and Reasonableness relating to health risk limits for groundwater (www.health.state.mn.us/divs/eh/risk/rules/water/hrlsonar08.pdf). What is actually described is an “endocrine effect”, and is not necessarily adverse. Elsewhere in this statement letter, MDH admits, “Because some effects observed may be normal compensatory responses, professional judgment is required to decide whether any particular effect is adverse4, or biologically significant5. If an endpoint is quantal (i.e., all or nothing), such as birth defects or tumors, designation of an effect as “adverse” may be a straight forward decision… However, for subtle effects and/or continuous measurements such as body weight or enzyme activity, this may ultimately be a qualitative decision. Professional judgment may be required to determine the point at which normal compensatory metabolic or physiological processes are compromised (EPA 2002c)” (emphasis added). The professional judgment in this case should come from authoritative bodies. In its response to the Coalition, MDH contends that a substance on the Minnesota CHC list would remain on the list only if the endocrine effects are reliable and observed at appropriate doses and time frames. Once again, this evaluation should come only from authoritative sources that employ Expert Panel reviews of the literature. Also, the Coalition urges MDH to reconsider qualifying the latter statement to focus only on adverse endocrine effects, rather than simply endocrine effects. Per their own assertions, some effects may be normal compensatory responses. Recommendation: Legitimate sources for endocrine disruption are those chemicals identified as known or likely endocrine disruptors using validated testing protocols in EPA’s Endocrine Disruptor Screening Program; those chemicals listed on the basis of endocrine‐disrupting properties in Annex XIV, List of Substances Subject to Authorization, Regulation (EC) No 1907/2006 of the European Parliament concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). MDH should limit the CHC list for endocrine disruption to these identified sources. iii. EPA’s TOXICS RELEASE INVENTORY (TRI) In terms of EPA’s TRI PBTs, the list of chemicals of high concern should have included only those that fulfilled the PBT criteria; as follows: PBT Criteria "Chemicals known as persistent in the environment, bioaccumulative and toxic" has typically included chemicals that meet the following criteria: 4
EPA has defined an “adverse effect” as “a biochemical change, functional impairment, or pathologic lesion that affects the performance of the
whole organism or reduces an organism's ability to respond to an additional environmental challenge” (EPA 2002c).
(www.health.state.mn.us/divs/eh/risk/rules/water/hrlsonar08.pdf)
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“Biological significance”: “Biological significance is the determination that the observed effect (a biochemical change, a functional impairment,
or a pathological lesion) is likely to impair the performance or reduce the ability of an individual to function or to respond to additional
challenge from the agent. Biological significance is also attributed to effects that are consistent with steps in a known mode of action” (EPA
2002c). ” (www.health.state.mn.us/divs/eh/risk/rules/water/hrlsonar08.pdf).
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1. Persistent in the environment means the chemical has a half‐life, as measured by reliable studies, equal to or greater than 180 days in water, or 180 days in soil, or 180 days in sediment, or 2 days in air. 2. Bioaccumulate means the chemical has a bioaccumulation factor (BAF) or bioconcentration factor (BCF), as measured by reliable studies, greater than 5000. 3. Toxic means a chemical has, as measured by repeat dose studies for mammalian toxicity or by acute or chronic studies for aquatic organisms, a subchronic oral No Observed Effect Level (NOEL) or No Observed Adverse Effect Level (NOAEL), value less than or equal to 10 mg/kg bw/day for mammals; or, LC50 or EC50 less than or equal to 1.0 mg/L (for acute toxicity) or a No Observed Effect Concentration (NOEC) less than or equal to 0.1 mg/L (for chronic toxicity) for aquatic species. Recommendation: Specifically, chemicals included should be from EPA’s several PBT related programs—EPCRA 313 PBT Program http://www.epa.gov/tri/lawsandregs/pbt/pbtrule.htm and the Waste Minimization Program http://www.epa.gov/osw/hazard/wastemin/priority.htm
Conclusion We urge a full consideration and screening of the Maine CHC list, per the recommendations above. This is necessary to ensure that Minnesota’s CHC list is built on authoritative conclusions and that the priority chemicals list that is being developed from the CHC list will withstand challenge and scrutiny. This Coalition greatly appreciates the opportunity to share this input with the Minnesota Department of Health and the Minnesota Pollution Control Agency. We look forward to continued engagement throughout this process and remain committed to assisting the Department in developing credible, deliberate, and workable lists for both chemicals of high concern and priority chemicals. If you have any questions or comments, please feel free to contact either Kevin Fisk with the Grocery Manufacturers Association at 616‐984‐6209 or Andy Hackman with the Toy Industry Association at 646‐520‐4851 as representatives of the Coalition. We look forward to our continued work together on this important public policy initiative. Respectfully Submitted by the Following: American Chemistry Council American Cleaning Institute Consumer Specialty Products Association Grocery Manufacturers Association Personal Care Products Council Toy Industry Association Cc: Michael Sandusky, Minnesota Pollution Control Agency Christopher J. Delaforest, The Office of Governor Tim Pawlenty 5